Label: AMBIX FIRST AID- dyclonine hydrochloride and phenol cream
- NDC Code(s): 10038-250-25, 10038-250-42
- Packager: Organics Corporation of America dba Ambix Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 4, 2019
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- Active Ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AMBIX FIRST AID
dyclonine hydrochloride and phenol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10038-250 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DYCLONINE HYDROCHLORIDE (UNII: ZEC193879Q) (DYCLONINE - UNII:078A24Q30O) DYCLONINE HYDROCHLORIDE 0.005 g in 1 g PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 0.005 g in 1 g Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MINERAL OIL (UNII: T5L8T28FGP) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10038-250-25 1 in 1 BOX 08/22/2013 1 25 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10038-250-42 1 in 1 BOX 08/22/2013 2 42.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/22/2013 Labeler - Organics Corporation of America dba Ambix Laboratories (061061164) Registrant - Organics Corporation of America dba Ambix Laboratories (061061164) Establishment Name Address ID/FEI Business Operations Suite K Value Added Services LLC 036822144 manufacture(10038-250)